Actavis Sued Over Digitek Heart Drug
1 CommentBy Ed Silverman // July 11th, 2008 // 11:46 am
A growing number of lawsuits have been filed against the Icelandic drug maker over charges that its recalled heart med was dangerous and defective, and led to one death, the Associated Press reports. Here is the latest suit.
The ligitation occurs not longer after Actavis this past April began a nationwide recall of all strengths of the Digitek pills, which are distributed by Mylan Pharmaceuticals and UDL Laboratories. Those two drugmakers were also named as defendants, and similar lawsuits have been filed in West Virginia and California.
Actavis said at the time that some tablets may have been double the usual thickness and so would contain twice the active ingredient, posing a risk of toxicity with symptoms from nausea and dizziness to low blood pressure and cardiac instability. The drugmaker noted that death can result from excessive intake of the active ingredient and that several reports of injuries had been received.
One of the New Jersey lawsuits, filed by the estate of Margret Lucille Crooker of Kemp, Texas, claimed the drug caused her “serious physical injury, pain and suffering” and she died on March 15.
According to published reports, a lawsuit filed by an Indiana woman hospitalized from an allegedly toxic overdose of Digitek in June, said that an FDA inspection at an Actavis plant had found deviations from good manufacturing practices that led to adulteration of drugs.
On Friday, an Actavis spokeswoman in the drugmaker’s New Jersey unit declined to comment on pending litigation, according to the AP.
Tom Lamb
There have been reports about a July 10 to August 10, 2006 FDA inspection of Actavis Totowa’s Little Falls, NJ, facility — where the company made its Digitek pills — during which investigators found significant deviations from Good Manufacturing Practices (GMP) regulations, including significant deficiencies in the company’s quality control unit.
Further, the FDA reportedly told Actavis that the company should promptly initiate an audit program by a third-party having appropriate GMP expertise in order to provide assurance that all marketed lots of drug products have their appropriate identity, strength, quality, and purity.
One wonders whether or not the FDA-suggested “audit program” was ever implemented by Actavis.
Given that production and release of double-dose Digitek pills were the types of things this audit was intended to prevent, I am skeptical.